Abiraterone Sandoz

Package Leaflet: Information for the User

Abiraterone Sandoz, 250 mg, Film-Coated Tablets

Abiraterone Acetate

Read All of This Leaflet Carefully Before Taking This Medicine Because It Contains Important Information for You.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• This Medicine Has Been Prescribed for You Only. Do Not Pass It on to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Experience Any of the Following Side Effects, or Any Other Side Effects Not Mentioned in This Leaflet, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Contents of the Pack

• 1. What Abiraterone Sandoz Is and What It Is Used For
• 2. Before You Take Abiraterone Sandoz
• 3. How to Take Abiraterone Sandoz
• 4. Possible Side Effects
• 5. How to Store Abiraterone Sandoz
• 6. Contents of the Pack and Other Information

1. What Abiraterone Sandoz Is and What It Is Used For

Abiraterone Sandoz Contains the Active Substance Abiraterone Acetate. It Is Used in Adult Men to Treat Prostate Cancer That Has Spread to Other Parts of the Body. Abiraterone Sandoz Works by Reducing the Amount of Testosterone in the Body; This Can Slow Down the Growth of Prostate Cancer.

When Abiraterone Sandoz Is Used at an Early Stage of the Disease in Response to Hormone Therapy, It Is Given Together with a Therapy That Lowers Testosterone Levels (Androgen Deprivation Therapy).

During Treatment with This Medicine, Your Doctor Will Also Prescribe Another Medicine Called Prednisone or Prednisolone. This Is to Reduce the Risk of High Blood Pressure, Fluid Retention, or Low Potassium Levels in the Blood.

2. Before You Take Abiraterone Sandoz

Do Not Take Abiraterone Sandoz

• If You Are Allergic to Abiraterone Acetate or Any of the Other Ingredients of This Medicine (Listed in Section 6).
• In Women, Especially During Pregnancy. Abiraterone Is Only Used in Men.
• If You Have Severe Liver Damage
• In Combination with Ra-223 (Used to Treat Prostate Cancer).

Do Not Take This Medicine If Any of the Above Applies to You. If You Are in Doubt, Consult Your Doctor or Pharmacist Before Taking This Medicine.

Warnings and Precautions

Before You Start Taking This Medicine, Discuss with Your Doctor or Pharmacist:

• If You Have Liver Problems;
• If You Have High Blood Pressure, Heart Failure, or Low Potassium Levels in the Blood (Low Potassium Levels in the Blood May Increase the Risk of Abnormal Heart Rhythm);
• If You Have Had Other Heart or Blood Vessel Diseases;
• If You Have an Irregular or Rapid Heartbeat;
• If You Have Shortness of Breath;
• If Your Body Weight Has Increased Rapidly;
• If You Have Swelling of the Feet, Ankles, or Legs;
• If You Have Taken the Medicine Ketokonazole in the Past to Treat Prostate Cancer;
• The Need to Take This Medicine with Prednisone or Prednisolone;
• The Possibility of Side Effects Related to Bones;
• If You Have High Blood Sugar Levels.

Tell Your Doctor If You Have Any Heart or Blood Vessel Disorders, Including Abnormal Heart Rhythms (Arrhythmia), or If You Are Taking Medicines for These Conditions.

Tell Your Doctor If You Have Yellowing of the Skin or Eyes, Dark Urine, Severe Nausea or Vomiting, Which May Be Signs of Liver Disorders. Rarely, Liver Disorders (Called Acute Liver Failure) May Occur, Which Can Be Life-Threatening.

Decreased Red Blood Cell Count, Decreased Sex Drive (Libido), Muscle Weakness, and (or) Muscle Pain May Occur.

Abiraterone Sandoz Must Not Be Taken in Combination with Ra-223 Due to the Possible Increased Risk of Bone Fractures or Death.

If You Plan to Take Ra-223 After Treatment with Abiraterone Sandoz and Prednisone/Prednisolone, You Should Wait 5 Days Before Starting Ra-223 Treatment.

If You Are in Doubt About Any of the Above, Consult Your Doctor or Pharmacist Before Taking This Medicine.

Blood Tests

Abiraterone May Affect Liver Function, and You May Not Have Any Symptoms.

During Treatment with This Medicine, Your Doctor Will Periodically Prescribe Blood Tests to Check the Effect of the Medicine on the Liver.

Children and Adolescents

This Medicine Is Not Used in Children and Adolescents. If Abiraterone Is Accidentally Swallowed by a Child or Adolescent, You Should Immediately Go to the Hospital with the Patient Information Leaflet to Show to the Doctor in the Emergency Department.

Abiraterone Sandoz and Other Medicines

Before Taking Any Medicine, Consult Your Doctor or Pharmacist.

Tell Your Doctor or Pharmacist About All Medicines You Are Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take. This Is Important Because Abiraterone May Increase the Effect of Many Medicines, Including Heart Medicines, Sedatives, Certain Anti-Diabetic Medicines, Herbal Medicines (Such as St. John's Wort), and Others. Your Doctor May Change the Dose of These Medicines. Other Medicines May Also Increase or Decrease the Effect of Abiraterone.

This May Result in Side Effects or Abiraterone Not Working Properly.

Androgen Deprivation Therapy May Increase the Risk of Abnormal Heart Rhythms. Tell Your Doctor If You Are Taking Medicines:

• Used to Treat Abnormal Heart Rhythms (Such as Quinidine, Procainamide, Amiodarone, and Sotalol);
• That May Increase the Risk of Abnormal Heart Rhythms [Such as Methadone (Pain Relief and Addiction Treatment), Moxifloxacin (Antibiotic), and Antipsychotic Medicines (Used to Treat Severe Mental Disorders)].

Tell Your Doctor If You Are Taking Any of the Above Medicines.

Taking Abiraterone Sandoz with Food

• This Medicine Must Not Be Taken with Food (See Section 3, "How to Take Abiraterone Sandoz").
• Taking Abiraterone Sandoz with Food May Cause Side Effects.

Pregnancy and Breastfeeding

Abiraterone Sandoz Is Not Used in Women.

• -This Medicine May Harm the Unborn Child If Taken by a Pregnant Woman.
• -If You Have Sex with a Woman Who May Become Pregnant, You Should Use a Condom or Other Effective Contraception Method.
• -If You Have Sex with a Pregnant Woman, You Should Use a Condom to Protect the Unborn Child.

Driving and Using Machines

It Is Unlikely That This Medicine Will Affect Your Ability to Drive or Use Tools and Machines.

Abiraterone Sandoz Contains Lactose and Sodium

• If You Have Been Told by Your Doctor That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicine.
• This Medicine Contains Less Than 1 Mmol (23 Mg) of Sodium per Dose, Which Means It Is Essentially "Sodium-Free".

3. How to Take Abiraterone Sandoz

Always Take This Medicine Exactly as Your Doctor or Pharmacist Has Told You. If You Are in Doubt, Consult Your Doctor or Pharmacist.

How Much to Take

The Recommended Dose Is 1000 Mg (Four 250 Mg Tablets) Taken Once a Day.

How to Take It

• Take by Mouth.
• Do Not Take Abiraterone Sandoz with Food.
• Take Abiraterone Sandoz at Least 1 Hour Before or at Least 2 Hours After Food(See Section 2, "Taking Abiraterone Sandoz with Food").
• Swallow the Tablets Whole with a Glass of Water.
• Do Not Crush the Tablets.
• Abiraterone Sandoz Is Taken with a Medicine Called Prednisone or Prednisolone. Take Prednisone or Prednisolone as Directed by Your Doctor.
• Take Prednisone or Prednisolone Every Day While Taking Abiraterone Sandoz.
• The Amount of Prednisone or Prednisolone You Take May Need to Be Changed. Your Doctor Will Tell You If You Need to Change the Dose of Prednisone or Prednisolone. Do Not Stop Taking Prednisone or Prednisolone Without Consulting Your Doctor.

Your Doctor May Also Prescribe Other Medicines for You to Take While You Are Taking Abiraterone Sandoz and Prednisone or Prednisolone.

If You Take More Abiraterone Sandoz Than You Should

If You Take More Abiraterone Sandoz Than You Should, Contact Your Doctor or Go to the Hospital Immediately.

If You Forget to Take Abiraterone Sandoz

• If You Forget to Take Abiraterone Sandoz, Prednisone, or Prednisolone, Take Your Normal Dose the Next Day.
• If You Forget to Take Abiraterone Sandoz, Prednisone, or Prednisolone for More Than One Day, Contact Your Doctor Immediately.

If You Stop Taking Abiraterone Sandoz

Do Not Stop Taking Abiraterone Sandoz or Prednisone or Prednisolone Without Consulting Your Doctor.

If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor, Pharmacist, or Nurse.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.

Stop Taking Abiraterone Sandoz and Contact Your Doctor Immediately If You Notice Any of the Following:

• Muscle Weakness, Muscle Tremors (Tremors), or Heart Palpitations (Palpitations). These May Be Signs of Low Potassium Levels in the Blood.

Other Side Effects Include:

Very Common(May Affect More Than 1 in 10 People):
Swelling of the Feet or Ankles, Low Potassium Levels in the Blood, Elevated Liver Function Test Results, High Blood Pressure, Urinary Tract Infections, Diarrhea.
Common(May Affect Up to 1 in 10 People):
High Lipid (Fat) Levels in the Blood, Chest Pain, Abnormal Heart Rhythms (Atrial Fibrillation), Heart Failure, Rapid Heartbeat, Severe Infections - Sepsis (Blood Infection), Bone Fractures, Nausea, Blood in the Urine, Rash.
Uncommon(May Affect Up to 1 in 100 People):
Adrenal Gland Disorders (Related to Electrolyte Imbalance), Abnormal Heart Rhythm (Arrhythmia), Muscle Weakness and (or) Muscle Pain.
Rare(May Affect Up to 1 in 1,000 People):
Lung Inflammation (Also Known as Allergic Alveolitis). Acute Liver Failure.
Frequency Not Known(Cannot Be Estimated from the Available Data):
Heart Attack, Changes in ECG (Prolonged QT Interval), and Severe Allergic Reactions, Causing Difficulty Swallowing or Breathing, Face, Lip, Tongue, or Throat Swelling, or Itchy Rash.
Bone Density Loss May Occur in Men Treated for Prostate Cancer. Abiraterone Sandoz in Combination with Prednisone and Prednisolone May Increase This Effect.

Reporting of Side Effects

If You Experience Any Side Effects, or Any Other Side Effects Not Mentioned in This Leaflet, Tell Your Doctor, Pharmacist, or Nurse. Side Effects Can Be Reported Directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.

Side Effects Can Also Be Reported to the Marketing Authorization Holder.

By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medicine.

5. How to Store Abiraterone Sandoz

• Keep This Medicine Out of the Sight and Reach of Children.
• Do Not Use This Medicine After the Expiry Date Which Is Stated on the Carton and Blister Pack. The Expiry Date Refers to the Last Day of That Month.
• No Special Storage Conditions Are Required.
• Do Not Throw Away Any Medicines via Wastewater or Household Waste. Ask Your Pharmacist How to Throw Away Medicines You No Longer Use. These Measures Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Abiraterone Sandoz Contains

• The Active Substance Is Abiraterone Acetate. Each Tablet Contains 250 Mg of Abiraterone Acetate.
• The Other Ingredients Are: Croscarmellose Sodium, Sodium Lauryl Sulfate, Povidone K30, Microcrystalline Cellulose Type 102, Lactose Monohydrate, Colloidal Anhydrous Silica, Magnesium Stearate (See Section 2, "Abiraterone Sandoz Contains Lactose and Sodium"). Opadry II 85F200051 Purple: Polyvinyl Alcohol, Titanium Dioxide (E 171), Macrogol 3350, Talc.

What Abiraterone Sandoz Looks Like and Contents of the Pack

Abiraterone Sandoz, 250 Mg, Film-Coated Tablets
White to Almost White, Oval, Film-Coated Tablets with "250" Engraved on One Side.
The Tablets Are Packaged in:

• Blisters of Aluminium/OPA/Aluminium/PVC or Aluminium/PVC/PE/PVDC Containing 120 Film-Coated Tablets in a Carton.
• Perforated Unit-Dose Blisters of Aluminium/OPA/Aluminium/PVC or Aluminium/PVC/PE/PVDC Containing 120x1 Film-Coated Tablets in a Carton.

Marketing Authorization Holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia

This Medicinal Product Is Authorized in the Member States of the European Economic Area (EEA) Under the Following Names

Bulgaria
Абиратерон 250 mg филмирани таблетки
Cyprus
Abiraterone PharOS 250 mg film-coated tablets
Czech Republic
Abiraterone Sandoz
Germany
Abirateron HEXAL 250 mg Filmtabletten
Denmark
Abirateron Sandoz
Estonia
Abiraterone Sandoz
Greece
Abiraterone/Sandoz επικαλυμμένα με λεπτό υμένιο δισκία 250 mg
Croatia
Abirateron Sandoz 250 mg filmom obložene tablete
Ireland
Abiraterone 250 mg film-coated tablets
Italy
Abiraterone Sandoz
Netherlands
Abirateron Sandoz 250 mg, filmomhulde tabletten
Norway
Abirateron Sandoz
Poland
Abiraterone Sandoz
Portugal
Abiraterona Sandoz
Sweden
Abirateron Sandoz
Slovakia
Abiraterón Sandoz 250 mg filmom obalené tablety

For Further Information on This Medicinal Product, Contact

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of Last Revision of the Leaflet:07/2024
(Logo of the Marketing Authorization Holder)